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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.

Z-1230-2015

January 27, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 70470
Status
Terminated
Classification
Class II
Quantity
11980 kits
Official record key
device-enforcement:Z-1230-2015

Official wording

Reason: ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)

Code information: Lot Numbers: 42565268 42624268 43538268 Exp. Date: May 22, 2015

Distribution pattern: Worldwide Distribution-US (nationwide), Austria, Bahrain, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech, Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Spain, South America, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and Vatican.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)